The countdown is on: The extended transition periods
The countdown is on: The extended transition periods for medical devices according to the Amendment Regulation (EU) 2023/607 offer some breathing space - but the first deadline is already in one year! So don't wait any longer and take this opportunity to ensure that your products and system meet the regulatory requirements and thus remain available on the market. Read on to learn why now is the perfect time to individually review regulatory conditions and how our expertise can help you advise, plan, and take the necessary steps in a timely manner.
On March 20, 2023, the European Union took a significant step in the regulation of medical devices: By publishing Regulation (EU) 2023/607, the transition periods for MDR recertification were extended to counteract potential bottlenecks in the healthcare sector.
But be warned: the extended transition periods are not a license for inaction.
After all, by May 26, 2024, the first conditions must already be met on the part of manufacturers - and that is actually just one year away!
Not every company will benefit from the extended transition periods: Individual check of prerequisites necessary!
Since the extended transition periods do not generally apply to all medical device manufacturers, it is essential that each company carefully analyzes the relevant prerequisites and decides individually whether it is affected by the deadline extensions and can benefit. In addition, the necessary steps must be planned in order to meet the regulatory requirements of Regulation (EU) 2023/607 on time.
In this regard, the conditions vary depending on the product category and affect, in particular, Class I (sterile), I (measuring function), IIa and higher medical devices with "legacy certificates" as well as devices to be up-classified according to Regulation (EU) 2017/745 on medical devices that were originally assigned to Class I.
Stay on top of the new requirements for manufacturers!
As we highlighted in a previous blog post, Regulation (EU) 2023/607 makes it mandatory to implement a quality management system by the deadline of May 26, 2024, according to Article 10 (9) MDR. In addition, it is necessary to submit a conformity assessment application to the relevant Notified Body by this date. Furthermore, manufacturers are required to conclude a written contract for certification in accordance with Annex VII Section 4.3 Subsection 2 MDR with a Notified Body by September 26, 2024, at the latest. Check which requirements you already fulfil or which measures you still need to implement by the first deadline next year.
Benefit from our expertise in the field of medical devices, conformity assessments and technical documentation!
While the extended transition periods offer an opportunity to meet the requirements of the MDR, time is running out. Don't hesitate to call on our expertise and support to ensure you understand all the requirements and can implement them on time. At TentaConsult Pharma & Med, we offer tailored advice and assistance in interpreting the prerequisites and conditions and fulfilling the requirements. Our experts support you in the implementation of a quality management system, the application, the preparation of the technical documentation and the preparation for the conformity assessment by the Notified Body. Our goal is to make the transition as smooth as possible for you and to keep your products successfully on the market.
Don't wait any longer: Contact us today!